Pressure application method

ABSTRACT

A method of treating sleep apnea by the novel application of pressure varying from ambient pressure to external portions of a patient&#39;s neck, and a novel breathing mask seal apparatus.

BACKGROUND OF THE INVENTION

This is a division of application Ser. No. 07/895,225, filed Jun. 8,1992, now U.S. Pat. No. 5,222,478.

In the art of respirators, resuscitators, and the like it is well knownto provide apparatus in the form of an enclosure which encompasses aportion of the human body such as the upper torso or thoratic regionthereof to provide within the confines of the enclosure a pressurecontainment chamber wherein pressure variations may be applied to thebody to stimulate respiration. A wide variety of such devices are known,the following prior art being representative.

U.S. Pat. No. 3,078,842 discloses a resuscitation apparatus whichemploys a rigid shell to enclose the torso of a human body. U.S. Pat.No. 4,523,579 discloses another rigid shell type body respirator havingflexible side walls. U.S. Pat. No. 2,241,444 discloses a respiratorjacket comprised of a rigid shell made by laying up reinforced plasterof paris material on a plaster cast which has been molded to the bodycontours of the individual user, and which includes an enlarged cavityconfronting the chest and adjacent abdominal region of the user. Otherrigid shell type resuscitators are disclosed by U.S. Pat. Nos. 4,257,407and 2,309,361. The latter of these discloses a padded liner in a rigidgenerally form-fitting respirator.

U.S. Pat. No. 2,899,955 discloses a respirator belt which encircles thewaist of a user and includes an inflatable bladder to which air pressureis directed for assisted breathing. U.S. Pat. No. 4,621,621 discloses arespirator including a rigid wire cage that encompasses a portion of auser's body and is in turn encompassed by an air tight cover to providea vacuum chamber surrounding the user's body. U.S. Pat. No. 3,577,977discloses a flexible, inflatable bladder-type jacket and U.S. Pat. No.2,480,980 discloses a rigid, generally form-fitting respirator jacket.Finally, U.S. Pat. No. 4,664,098 discloses a cardio-pulmonaryresuscitator which is worn by a patient in the manner of a beltencompassing the abdominal region.

Notwithstanding such known devices, practitioners in the art havecontinued to seek improved body respirators. For example, improvementshave been continually sought in body respirator compactness,portability, user comfort, reduced power requirements, and of courseimproved therapeutic efficacy.

Also known in the prior art are a variety of vacuum devices forimmobilizing a part of a body. The Rapid Form™ brand vacuum splint isone example. Such devices utilize a structure known as vacuum beads toprovide a selectively rigid or flexible member that is used, for exampleas in the case of the above specified vacuum splint, to immobilizeselected body parts that have sustained bone fractures or the like. Suchknown devices generally comprise a thin section airtight envelope filledwith material such as styrofoam beads which interengage and deform uponapplication of a vacuum within the envelope to thereby render the vacuumbead material relatively rigid. The rigid vacuum bead material thus isutilized to immobilize a selected body part.

BRIEF SUMMARY OF THE INVENTION

The present invention contemplates a novel and improved body respirator,resuscitator, pressure or pulse monitoring apparatus or similarapparatus such as a wrap or sheath, or a breathing mask which isuniversal in its application by virtue of its being very closelyform-fitting for any selected user irrespective of variations in bodysize or contours from one user to another. The invention also is lightin weight and compact, imposes minimal power requirements for its use,and provides greatly enhanced user comfort and therefore enhanced usertolerance. The invention thus provides greatly enhanced convenience forthe user as well as for emergency rescue teams and others who mayencounter the need for regular access to emergency equipment of thissort, among other advantages. The invention also contemplates a noveland improved method for the use of varying pressures in a variety ofmedical applications.

The apparatus of this invention contemplates, in one of severalpresently preferred embodiments, a body enclosure comprised of a sheathor wrap of selectively flexible or rigid material, such as the abovecharacterized vacuum bead structure or the like, formed to encompass aselected body portion and including seals to seal perimeteral portionsor other portions of the body sheath, for example to seal about theopenings through which adjacent body portions project such as at thewaist, neck, or arms.

The sheath is adapted to be placed in closely spaced form-fittingrelation encompassing a portion of the user's body to define, in a zonebetween the sheath and the user's body, a very thin-section chamber orspace. The sheath is then selectively rigidified, as by application of avacuum if comprised of conventional vacuum bead material, to form arigid, form-fitting enclosure about the encompassed portion of thepatient's body whereby the chamber or space between the sheath and theuser's body is provided with a rigid outer wall which closely conformsto the adjacent body contours of the user. Pressure or vacuum generatingequipment may be utilized to apply pressure variations within this spaceto act on the flexible inner wall (i.e. the user's body) to assist userventilation or for other purposes. Alternatively, the pressure withinthe space may be observed to monitor user pulse, breathing, or the like.

Because the sheath is selectively rendered rigid or flexible, it isquite compact and easily stored when not in use. Because it is placedabout the user's body in a flexible state, it is universal inapplication and extremely closely form fitting with the attendantbenefit that the containment space defined between the sheath and theuser's body is of minimal volume. Effective operation thus is achievedwith minimal power requirements and minimal required compressor orvacuum pump delivery rates.

The invention additionally contemplates spacer means disposed within thepressure containment space between the sheath and the user's body so asto define a predetermined minimal spacing therebetween so that the formand volume of the pressure containment space may be readily controlled.The spacer means is of a structure (e.g. open cell foam) to permitpressure variations introduced at one point within the containment spaceto be transmitted throughout the space even if the spacer means issubstantially co-extensive with the pressure containment space.

The invention additionally contemplates a novel and improved method ofpressure utilization in conjunction with the body of a user withadvantages corresponding to the above noted and other advantages of thenovel apparatus.

It is accordingly one object of the invention to provide a novel andimproved body respirator, resuscitator, or the like.

It is a further object of the invention to provide an improved apparatusand method for the utilization of external pressure in the medicaltreatment of a patient.

A more specific object of the invention is to provide a selectivelyrigid, flexible body wrap, sheath, mask, vest, or similar apparatuswhich is adapted to encompass a portion of a body to thereby define inconjunction therewith a sealed space adjacent the body such thatpressure controlling or monitoring means cooperable with the sheath isoperable to selectively vary or monitor the pressure within the sealedspace.

These and other objects and further advantages of the invention will bemore readily understood upon consideration of the following detaileddescription and the accompanying drawings, in which:

FIG. 1 is a frontal elevation of one presently preferred embodiment ofthe instant invention;

FIG. 2 is a side elevation, partially broken away to show details of analternative embodiment of the invention shown encompassing the body of auser;

FIG. 3 is an enlarged detailed portion of FIG. 2 including schematicrepresentation of a vacuum pump and pressure controller according to onepresently preferred embodiment of the invention;

FIG. 4 is a perspective view of a wrap or sheath apparatus according toan alternative embodiment of the invention; and

FIG. 5 is a sectioned side elevation of a breathing mask or similarapparatus according to another alternative embodiment of the invention.

There is generally indicated at 10 in FIG. 1 a body respirator or thelike constructed according to one presently preferred embodiment of theinvention and including a body sheath 12 formed for purposes of thisembodiment as a vest or jacket and including, when enclosed about theuser's body, a neck opening 14 as well as arm holes or apertures 16.

Suitable fasteners are provided, for example Velcro™ or similarinterengaging tapes, to maintain a front opening 18 tightly closed andsealed when the vest is donned and in use, and to thus maintain thesheath 12 in closely form-fitting relation about the upper torso orthoratic region of the user's body.

An alternative form of the sheath or vest as identified at 12' in FIG. 2passes beneath the arms of the user so no arm holes are required. Thesheath 12' encompasses the user's waist and upper chest. For theembodiments shown in FIGS. 1 and 2, all openings from which parts of theuser's body project are sealed by suitable seal means such asencompassing band means 20 to form intermediate the sheath and the body22 (FIG. 2) of the user a sealed space or chamber 32.

Other differences of the FIG. 2 embodiments from that of FIG. 1 includebuckle and strap fasteners 24 in lieu of fasteners 17 and the locationof closure 26 of adjacent one side of the user's body rather thanextending vertically along user's front as does opening 18 of the FIG. 1embodiment. Of course, a wide variety of alternative configurations maybe utilized in accordance with the specific purposes and desiredfeatures of the sheath 12. Specifically, an apparatus according to thisinvention but adapted to encompass a body part other than the chest orabdominal region will of course be configured accordingly.

Regarding further aspects of the invention, as exemplified by FIG. 2,sheath 12' comprises a selectively rigid or flexible wall system 28which is maintained in closely spaced relationship with respect to theuser's body 22 as by means of spacers 30, which may be of such suitablestructure as open cell foam to permit the transmission of pressurevariations imposed at one location within the confines of the sheath 12'to all locations therein.

The spacers 30 may occupy only a small portion or alternativelysubstantially all of the volume of the space 32 defined intermediatesheath 12' and the user's body 22, within the confines of perimeteralseals 20. It will be noted, however, that space 32 need not becoextensive with the mutually contiguous zones of sheath 12' and theuser's body 22, that spacers 30 may be of other suitable structure ormay be eliminated entirely, and that seals 20 need not be disposed aboutperimeteral portions of the sheath 12' where portions of the user's bodyextend therefrom.

The invention thus contemplates an apparatus which is utilized to form asealed space between a body sheath and a user's body with the sealedspace being defined generally by an inner wall system comprised of aportion of the user's body, an outer wall system comprised of acorresponding adjacent portion of a sheath wall disposed in closelyspaced form-fitting relation with respect to the user's body. A sealsystem seals all interfaces between the sheath and the user's body thatare exposed to pressure variations introduced within the sealed space.

It is noted that seals are to be provided to seal any opening which isprovided to facilitate installation or removal of the sheath, forexample opening 18 of FIG. 1 or 26 of FIG. 2. These and any other suchopenings would require seals to preclude leakage due to a pressuredifferential between ambient and the pressure condition within space 32.

There is shown in FIG. 3 a portion of the novel body respirator. In FIG.3, sheath 12' is comprised of an outer flexible shell 34 of sheetpolyethylene for example, which is coextensive with the selectivelyrigidified structure 36. Structure 36 comprises a pair of flexible,closely spaced, air impermeable inner and outer walls 38 and 40 of suchsuitable material as vinyl or polyeurethane impregnated nylon. The innerand outer walls 38 and 40 are sealed together along a continuous lineencompassing a space 42 therebetween, which space 42 contains a mass ofinterengageable elements 44 such as beads of styrofoam brand plastic.Air permeable partition elements 41 joined to and extending betweenwalls 40 and 38 may be provided at intervals in space 42 as barriers toprevent undesirable migration of beads 44 within the space 42.

As is known, the above described structure is typical of vacuum beadtype systems wherein the application of a vacuum within space 42, as bymeans of a vacuum pump 46, causes walls 40 and 38 to collapse inwardlyunder the impetus of external ambient air pressure against the beads 44.Thus, upon imposition of such a vacuum in space 42, the styrofoam beads44 deform in interengagement and lock up in an immobilized state to forma rigid shell from the previously flexible shell. Upon release of thevacuum drawn within space 42, the styrofoam beads 44 are released fromtheir mutual interengagement and the vacuum bead structure 36 becomesonce again flexible.

Carried adjacent the inner wall 40, and preferably affixed thereto in asuitable manner is the spacing material 32 as above characterized. Inuse, the innermost extent of the spacing material 32 engages the body ofthe user 22 to thereby establish and maintain a generally uniformspacing or separation between the sheath 12' and the user's body 22.

Of course, the spacing therebetween is uniform only if the spacerelement 32 is of uniform thickness. More generally, the spacing betweensheath 12' and user's body 22 may vary according to variation in thethickness of the spacing elements 32. Also, and as noted hereinabove,the spacing element 32 may be omitted entirely as it is contemplatedthat only a very thin section space generally is necessary between theuser's body and the sheath 12' for effective operation of the invention.

As further shown in FIG. 3, the invention additionally comprises apressure controller 48 which is powered by any suitable and conventionalpower means to deliver air flow under pressure to space 32 in order toimpose within space 32 controlled pressure at variance with ambientatmospheric pressure. For example, pressure controller 48 may beutilized to impose alternating or cyclic elevated pressure within space32, or a partial vacuum.

In order to accommodate the pressure controller 48, a suitable air flowdelivery conduit 50 provides an air flow path between pressurecontroller 48 and space 32, and of course therefore traverses the sheath12'. In a preferred embodiment the sheath 12' will include a port meanshaving any suitable, known coupling 51 or air conduit connection on theouter side thereof for connection to a delivery conduit from pressurecontroller 48.

For emphasis it is reiterated here that the apparatus of this inventionmay take any of a variety of forms to encompass any portion of a user'sbody other than the chest or thoratic region and for a variety ofpurposes other than respiratory assistance. For example, an apparatussimilar in many salient respects to that above described andencompassing the thoratic region may be utilized with alternatingpressure, and in conjunction with alternating pressure delivered in aspecified phased relationship to the airway of a patient to function asa heart pump for cardio-vascular resuscitation. In another alternativemode of use, the apparatus of this invention may be utilizied withpressure monitoring equipment 49 (FIG. 3) which is connected via aconduit 53 to space 32 for the purpose of monitoring pressure therein.Thus any physical response of a user which causes variation of thepressure within space 32, pluse or spontaneous breathing for example,may be observed by use of pressure monitor 49.

The invention may also be embodied as a wrap or sheath as abovementioned, for example a wrap or sheath for a limb or other extremity.FIG. 4 shows such a wrap or sheath 60 which is adapted to encompass ahuman limb or any similarly configured body part, for example, the neck.The sheath 60 is comprised of an elongated flexible band 62 which formsan elongated, thin section envelope 64 that contains therein materialsuch as styrofoam beads similar in all salient respects to the abovedescribed vacuum bead structures. Fastener bands 66 are affixed adjacentone longitudinal end of band 64 as by stitching 68 and cooperatingfastener strips 70 are similarly affixed adjacent the opposed end ofband 62. Fastener strip 66 and 70 may be cooperating hook and loop typefastener strips such as Velcro™ brand fastener material.

Sheath 60 may also include seal means such as a patch seal 72 in theform of a foam rubber or similar sealing strip affixed to one side ofband 62 intermediate its longitudinal ends and forming thereon a closedperimeter which defines within its confines a space 74. A suitablevacuum connection 76 communicates with space 74, for example bypenetrating the band 62 via a fitting 78 within the confines of seal 72.The sheath 60 thus may be applied to a human limb or similarlyconfigured body part as a wrap with the fastener strips 66 and 70overlapping to maintain the band 62 in encompassing relationship on sucha body part and with an outer seal surface 80 of seal member 72 engaginga corresponding surface portion of such body part continuously along theextent of seal 72. By application of vacuum as via a vacuum connection82, the band 62 may be selectively rigidified in encompassingrelationship about a human limb as described. In an alternativeembodiment, the selectively rigidified part of band 62 may be limited tothat part encompassed by seal 72.

For either embodiment, the application of vacuum to the band 62 asdescribed forms a relatively rigid outer wall for space 74 with theinner wall thereof being that portion of the patient's body encompassedby seal 72. Accordingly, pressures varying from ambient atmosphericpressure may be applied for therapeutic effect to that portion of thepatient's body exposed to such pressure variation within the confines ofseal 72 in much the same manner as pressure variations are applied tothe upper thoracic region as above described with reference to FIGS. 1through 3.

Specifically, since the outer wall of space 74 is rigid, the applicationof elevated pressure above ambient pressure via connection 76 in space74 will tend to compress the corresponding adjacent portion of thepatient's body which forms the inner wall of space 74 whereas a partialvacuum within space 74 will tend to distend the adjacent body portion bydrawing it into the space 74.

Another alternative embodiment of the invention is shown in FIG. 5 as abreathing mask 83 having a generally rigid body 84 which carries a sealassembly 86 that encompasses an open space 88 which communicates throughbody 84 with a gas supply connection portion 90 of mask body 84.Accordingly, mask 83 may be placed with seal assembly 86 in confrontingengagement with a user's face so that seal assembly 86 encompasses thenose or the nose and mouth of a user. Breathing gas for the user is thensupplied exclusively through connection 90.

Since the function of a breathing mask such as shown in FIG. 5 differsfrom the function of a body type respirator such as shown in FIGS. 1through 3, the expanse of space within the confines of seal 86 need notbe enclosed by the vacuum bead material to provide a rigid outer wallsuch as is required for the respirator of FIGS. 1 through 3. Rather, forthe FIG. 5 embodiment of the invention, the function of vacuum beadstructure as described hereinbelow is to provide an effective and andclosely conforming surface seal to fit a wide variety of user facialcontours in more or less universal fashion whereby a single mask may bereadily adapted for use by virtually any patient.

Accordingly, it will be seen that seal assembly 86 comprises a flexibleperimeteral wall system 92 comprised of rubber for example, and formedin a closed ring with a generally tubular cross section. The space 94closed within the wall system 92 is filled preferably with vacuum beadmaterial such as above described with reference to FIGS. 1 through 3,for example styrofoam plastic beads.

The resilient wall element 92 is mounted upon mask body member 84 andextends outwardly therefrom, and a seal member 96 may be affixed to anouter extent of wall element 92 for confronting sealing engagement witha user's face. A vacuum connection 98 is provided to permit drawing apartial vacuum upon space 94 with seal 96 in engagement with thatportion of a user's face encompassing the nose or the nose and mouth.The partial vacuum, acting on the mass of interengageable beads, causesthem to become forcefully interengaged under the impetus of ambientatmospheric pressure compressing the flexible wall element 92 inwardly.The mass of beads thus becomes rigid and supports the wall 92 againstinward collapse. The wall 92 thus holds whatever form it and thecontained beads have assumed by virtue of sealing pressure against theface of a user. Accordingly, the mask 83 is effective universally forany user as the seal thereon readily conforms, and is maintained inconforming relationship to the user's face by virtue of operation of thevacuum bead apparatus as described.

For purposes of this invention, including all embodiments describedhereinabove, the structure of the vacuum bead material may include avariety of alternatives including styrofoam beads as above described oralternatively a finely divided powder with similar mechanicalproperties. Additionally, the material within the vacuum envelope may beinfused or coated with a bonding agent such as a heat curing adhesive topermit the set or shape of the vacuum bead structure, once establishedby the vacuum action, to be permanently maintained. This is done bysubjecting the vacuum bead material to sufficient activating or curingenergy such as heat for curing a heat cured adhesive. Other types ofbonding systems may also be used, for example chemical curing systems,pressure sensitive adhesives, photosensitive or light curing systems,and so forth. Any adhesive will suffice which provides the function ofmaintaining the shape or form of the vacuum bead structure after releaseof the vacuum by bonding the individual vacuum beads or similar elementstogether. Some adhesive systems, such as heat curing or heat settingadhesives, would for all practical purposes be limited to use in astructure as described which is to be permanently maintained in the formsuited to a particular user. That is, once the heat setting adhesive iscured, it would not be possible re-use the same adhesive. By contrast, ahot melt adhesive or similar bonding system would permit re-use of amask or respirator structure according to this invention for anotheruser as the bonds between interengaged vacuum beads could be broken bymechanical force (i.e. massaging or kneading the vacuum bead envelope).The mask or respirator could then be fitted to a different user, thevacuum applied to maintain the resulting seal and/or spaceconfiguration, and the vacuum bead material then once again subjected toheat to melt the adhesive and bond the vacuum bead materials in the newconfiguration.

The seal 96 of FIG. 5 or corresponding seal elements from otherdisclosed embodiments similarly may take a variety of forms including arubber surface seal as shown, or alternatively an inflated bladder sealfilled with air, foam or gel, a flap seal, or the like. Any of these mayinclude a tacky outer surface for engagement with the respective bodypart of a user to provide sealing with a user's body in part bytemporary, releasable adhesion to the skin. Another seal structurecontemplated includes a closed envelope containing a hydroscopic gelmaterial which has cushioning properties and a tacky character such thatthe seal is resilient at low mechanical loads but is permanentlydeformed by larger loads. The air filled bladder seal generally may be atubular bladder with air space encircling a space similar to 94 thatcontains therein vacuum bead material or any alternative as abovediscussed. In addition, it is contemplated that the outer surface ofwall 92 may function itself as a seal for confronting engagement with abody portion of a user such that a separate seal member such as at 96 inFIG. 5 may be entirely eliminated.

In an additional alternative embodiment applicable to any of the abovedescribed structures, the invention may be comprised of a body memberwhich carries a separate, replaceable vacuum bead liner structure asopposed to having the vacuum bead structure permanently installed withother elements of the invention.

One advantage of the mask structure of FIG. 5 is that when vacuum isapplied via connection 98, the vacuum bead material 95 will bemaintained in a rigid form defining an outer profile for sealing inclose conformity to the face of a user; however, if leaks should bepresent in such a seal, the vacuum bead material 95, even when undervacuum, can be formed or molded by the application of mechanicalpressure (i.e. finger pressure) to change the seal profile orconfiguration. Accordingly, if leaks are detected after application ofvacuum, the medical practitioner can eliminate such leaks with merefinger pressure applied against wall element 92 adjacent the leak. Suchmechanical pressure will displace the wall 92 inwardly thus moving ordisplacing the immediately adjacent vacuum beads. Since under suchrelatively small and non-uniform mechanical pressures the individualbeads are not significantly compressed but merely redistributed,mechanical finger pressure as described will force some of the vacuumbead material outwardly in the direction of seal 96 to thereby close theleak. Thus, with the combination of direct fitting to the face of theuser, application of vacuum to maintain resulting shape, application ofmechanical pressure as needed to effect proper seal conformity with theuser's face, and finally application of heat or other mechanism to setan adhesive supplied within space 94 to the vacuum bead material 95, themask 83 provides for a custom fit to any user, which custom fit is thenmaintained indefinitely for as long as that user must use the mask. Thesame mask may then be reused to fit any other user with a similar customfit to provide seal integrity of equal quality.

In still another alternative embodiment of the invention, the vacuumbead material 95 may be supplanted entirely by a heat cure or similaradhesive in powder, granular or bead-like form. Although such astructure is believed to be less useful for repeated universalapplications, it would be the equal of other above described embodimentsfor providing a closely conforming seal in a single use for any userirrespective of differences in facial contours.

Entirely similar structural alternatives as above disclosed also arecontemplated for the embodiments of FIGS. 1 through 4 inclusive, and forstill further embodiments not heretofore discussed, For example, thedisclosed mask structure also contemplates such alternatives as a maskeffectively functioning as a perimeteral seal with nasal cannulaeprotruding within space 88 to be received into the nares of a user.

From the above description, the novel method will also be apparent asincluding, inter alia, the steps of encompassing or enclosing apatient's body portion with a flexible structure including a seal toprovide sealing against selected body portions to form a chamber orenclosed space, and rigidifying at least a part of the structure toprovide a rigid boundary for a corresponding part of the enclosed space.Then one may selectively vary the pressure condition within the enclosedspace from ambient either at will or in a predetermined program ofpressure variation, or by voluntary or involuntary patient response, andas a further optional step, such pressure variation occurring within theenclosed space may be monitored.

According to another aspect of our novel method, the encompassing of apatient's body portion with a flexible sheath as hereinabove specifiedmay be performed as a treatment for obstructive sleep apnea. Sleep apneais a widespread sleep disorder estimated to affect up to 3% or more ofthe general population and commonly characterized by occlusion orobstruction of the upper airway in sleep with resultant disruption ofbreathing and sleep patterns. The condition carries potential seriousconsequences including oxygen starvation.

The method of the invention accordingly contemplates the application ofnegative pressure (i.e. pressure below ambient atmospheric) at least tofrontal areas of a patient's neck to thereby draw out or distend theadjacent tissue thus permitting the relatively elevated ambient pressurein the airway, or artificially elevated pressure therein such as CPAP(continuous positive airway pressure), to expand or distend the upperairway thereby relieving the airway obstruction.

According to the description hereinabove there is provided by theinstant invention a novel and improved method and apparatus for theexternal application of pressure variations to a portion of a user'sbody. The invention may be utilized to apply pressure at decreased orelevated magnitude with respect to ambient, or in a program of varyingpressure magnitudes applied by automatic or manual control, or evenpressure variations from ambient or from elevated or decreased pressuremagnitudes resulting from voluntary or involuntary user response. Theinvention further contemplates the monitoring of any such pressuremagnitude or variation thereof.

Respecting the FIG. 1 through 3 embodiments, the invention alsocontemplates an apparatus comprised of separate inner garment, vacuumbead shell, and outer garment structures. The inner garment may be, forexample, a foam rubber shell bonded to a fabric backing for the purposeof separating the vacuum bead structure from the user's body. The outergarment may be of the character above described with reference toflexible shell 34, and may include all of the requisite seals such asthe described seals 20. Thus it will be clear that the above describedcomponents of the invention may be integrally formed together, formedseparately and permanently or separably connected, or formed separatelyand applied one over the other to make up a flexible body enclosingsheath apparatus as above described.

As the inventors herein, we have contemplated these and otheralternative and modified embodiments, and certainly such would alsooccur to others versed in the art once they were apprised of theinvention. Accordingly, it is intended that the invention be construedbroadly and limited only by the scope of the claims appended hereto.

We claim:
 1. In the medical treatment of sleep apnea syndrome, themethod of treatment comprised of applying to frontal portions of apatient's neck a pressure sufficiently less than ambient pressure todistend adjacent neck tissue in a manner effective for alleviatingobstruction of the patient's airway in sleep.
 2. The method as set forthin claim 1 including the additional step of simultaneously applying anelevated pressure greater than the first mentioned said pressure withinthe patient's airway.
 3. The method as set forth in claim 2 wherein saidelevated pressure is of a magnitude greater than ambient atmosphericpressure.